31 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NAWALUTION SKIN AND WOUND CLEANSER
FDA 510(k)
FDA Unclassified
·Unknown
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304006829·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1416600·14mm H x 16mm W x 60mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X141660120·14mm H x 16mm W x 60mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L141660120·14mm H x 16mm W x 60mm L XLIF Trial 12 degree L...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X14166080·14mm H x 16mm W x 60mm L x 8 degrees XLIF
TRIMEDYNE HOLMIUM LASER SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8
FDA 510(k)
FDA Class 2
·Cardiovascular
BD ULTRA-FINE INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·September 16, 2019
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065402·Corpectomy, 14Dx16Wx60H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929038956·Corpectomy, 14Dx16Wx60H 6°
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
FDA Adverse Event
Injury
·BIOMET, INC.·Product code JDI·October 4, 2023
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
FDA Adverse Event
Injury
·BIOMET, INC.·Product code JDI·October 4, 2023
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
FDA Adverse Event
Injury
·BIOMET, INC.·Product code JDI·October 4, 2023
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 27, 2011
PKG, ALLIS FORCEPS, P/N 0250080240. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
MAXIM KNEE SYSTEM -FML AUG BLT 65X10ML/LR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017
AGC TOTAL KNEE PROSTHESIS - INTLK FMRL 65 RT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017